Fellow, Clinical Scientist
Marlborough, MA, US, 01752
Additional Location(s): US-MA-Marlborough; US-MA-Boston; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Natick; US-MA-Quincy
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role:
The Fellow, Clinical Scientist will provide SHV & Accessories clinical therapeutic area expertise inclusive of competitive landscape to develop strategies for clinical trial design, including clinical trial protocol development, regulatory submissions, clinical study data analysis and dissemination. This incumbent is responsible for the strategic direction for clinical trial scenarios in collaboration with various internal (Clinical Project Management, Regulatory, Medical Safety, Biostatistics, Medical Writing, HEMA, R&D and Quality) and external experts or agencies to assist in clinical strategy, the development of study designs and clinical study data analysis and dissemination. As the subject matter expert for their field whereby, they are integral in developing and aligning on the clinical evidence strategy for their respective device.
Work Mode:
This role follows hybrid work model, requiring employees to be in our BSC local office at least three days per week.
Visa Sponsorship
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position.
Your responsibilities will include:
⦁ Encourages innovation and boundary breaking in the development of clinical trial strategic direction within clinical scientific, therapeutic areas (inclusive of competitive landscape) and medical device expertise. Recognized as a subject matter expert in clinical organization, clinical trial team and cross-functionally.
⦁ Authors and/or is consulted on clinical trial protocols/designs (pre-market and post-market) and regulatory reports (e.g. Clinical Study Reports, Annual Reports, Clinical Summaries) in support of mandated regulatory requirements, product approval and indication expansion.
⦁ Clinical Subject Matter Expert for Product Development Teams, acting as clinical core team representative for NPD (New Product Development) and/or PDP (Product Development Process).
⦁ Knowledge of statistical output and clinical data analysis from BSC and competitors’ medical device clinical trials and registries and determines appropriate evaluation, interpretation, and presentation of data
⦁ Collaborates with clinicians and medical writers on planning and development of white papers, manuscripts and abstracts for submission and publication in peer reviewed scientific journals. Collaborates with clinicians and medical writers on planning and development of slide presentations, and poster presentations for scientific meetings/congresses worldwide.
⦁ Established network of strong relationships with internal and external scientific, medical and technical experts to support clinical and product strategies including study and site clinicians and investigators.
⦁ Authors and/or is consulted on presentations as needed to worldwide regulatory agencies, Study Investigators/Steering Committee Meetings, Medical Advisory Board (MAB), and interacts as needed with Key Opinion Leaders (KOL), Primary Investigators and Site Investigators.
⦁ Stay abreast of current clinical practice and competitive landscape. Keeps abreast of current trends, new technologies, analyzes scientific data, and attends scientific congresses. Proactively shares information with peers, management, senior management and cross-functional leadership.
Required qualifications:
⦁ Bachelor's degree in medical, biological sciences or field associated with clinical research
⦁ Minimum 10 years of medical device clinical trial experience
⦁ Proven knowledge of Good Clinical Practices (GCP), ISO 14155 and FDA regulations governing the conduct of clinical trials.
⦁ Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships
Preferred qualifications:
⦁ Advanced degree in medical, biological sciences or field associated with clinical research.
⦁ Experience in structural heart and/or interventional cardiology preferred
Requisition ID: 603926
Minimum Salary: $ 127900
Maximum Salary: $ 243000
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
Nearest Major Market: Boston
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